Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241777. Device: SmartAdjust Technology. Applicant as listed: Insulet Corporation. Decision date: 2024-08-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241787. Device: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care U.S., Inc.. Decision date: 2024-08-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241534. Device: VITROS Immunodiagnostic Products Syphilis Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2024-08-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220908. Device: Ensol EnTM Specimen Collection and Transport System. Applicant as listed: Ensol Biosciences, Inc.. Decision date: 2024-08-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233932. Device: Alinity i Toxo IgM. Applicant as listed: Abbott Laboratories. Decision date: 2024-08-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241427. Device: Access Syphilis. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-09-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220999. Device: Hipro Glycosylated Hemoglobin (HbA1c) Test System. Applicant as listed: Shijiazhuang Hipro Biotechnology Co., Ltd.. Decision date: 2024-09-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234063. Device: T2Candida 1.1 Panel. Applicant as listed: T2biosystems, Inc.. Decision date: 2024-09-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241335. Device: Eversense 365 Continuous Glucose Monitoring (CGM) System. Applicant as listed: Senseonics, Incorporated. Decision date: 2024-09-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240041. Device: IVD CAPSULE PSP; abioSCOPE. Applicant as listed: Abionic SA. Decision date: 2024-09-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240854. Device: Accelerate Arc System. Applicant as listed: Accelerate Diagnostics, Inc.. Decision date: 2024-09-26.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242540. Device: AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2024-09-27.
Source: api.fda.gov · Retrieved 2026-10-19
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.